- Bachelor's or master's degree in Computer Science, Technical Communication, English, Life Sciences, or a related Engineering field (e.g., Biomedical).
- Ability to manage translation workflows for global markets and lead small projects, including training or mentoring colleagues to ensure high product quality and customer satisfaction.
- Working knowledge of key regulations, including FDA 21 CFR Part 820/Part 11, ISO 14971 (Risk Management), and GAMP 5, with the ability to maintain strict adherence to corporate style guides.
- Proven track record of integrating AI-driven workflows and Cloud capabilities to streamline the content lifecycle and enhance the delivery of global user documentation.
- 3-6 years of skilled technical writing or software validation testing experience in a strictly regulated environment such as Medical Devices, IVD, or Biotechnology.
- Strong experience in Adobe InDesign, Adobe Photoshop, Adobe Illustrator, and Camtasia for video creation.
- Proven experience creating regulatory-compliant documentation (such as IFUs, User Manuals, or QRIs) that meets FDA,



EU MDR/IVDR, and ISO 13485 standards.
- Mastery of professional authoring tools (e.g., Vasont, MadCap Flare, FrameMaker) and a strong working knowledge of document management and version control systems.
- Excellent interpersonal and writing skills, with the self-motivation to quickly learn new molecular diagnostic technologies, such as PCR and clinical lab workflows.
- Perform duties as an individual contributor and team member with 100% hands-on work to develop, review, update, and publish regulatory-compliant documentation, including IFUs, Product Manuals, Getting Started Guides, and Service Manuals.
- Document product functionalities and manage documentation reviews to verify that technical information for Xpert tests and GeneXpert systems.
- Collaborate with Regulatory Affairs and Clinical teams to ensure documentation meets user needs and technical accuracy within a regulated env

📌 Technical Writer Professional (Bengaluru)
🏢 ItConnectUS
📍 Bengaluru